Scientific, regulatory, and economic challenges have contributed to a slow rate of antimicrobial innovation that is outpaced by and insufficient for the urgent public health threat of antimicrobial resistance (AMR). The research and development process is time- and cost-intensive, with a high failure rate and a market that does not support continued investment. The current volume-based model for payment is at odds with antimicrobial stewardship (AMS) principles of responsible use. Compounding this problem, antimicrobials are not valued appropriately for their patient and population health benefits.

With this in mind, the Policy & Government Affairs (PGA) Committee of SIDP has drafted the following position statement to assist our society in communicating our position on antimicrobial development. 

Please review the statement attached here, and add any comments in the forum by December 11, 2023.  The PGA Committee and the Board will consider all comments in preparing our final position statement. The final statement will ultimately be posted on our website and used as a guide to promote future discussion and initiatives pertaining to antimicrobial drug development.  

I love the Open Access section!

Considerations:

• “CURE ID lowers the time investment for providers to share case reports and expands access to case report and clinical trial data”
  
• CURE ID should be referenced or linked to.   CURE-ID (ncats.io)

• “The Critical Path Institute is making strides toward…”
• Critical Path Institute should be referenced or linked to.   Critical Path Institute (c-path.org)

  Page 3

• “Examples include releasing data on LPAD/QIDP application annually, total NTAP incentives paid each fiscal year…”
• QIDP is not defined before this in the body of the document.
• NTAP is not defined before this in the body of the document.

•  “infections/limited indications is aligned with the Cures Act (aka H.R. 34 or the 21st Century Cures Act) goal of accelerating research to prevent and cure serious illnesses through novel mechanisms.”
• I believe there would be value in linking to the Cures Act in the body of the document or an appropriate summary of the Act.
• BILLS-114hr34enr.pdf (govinfo.gov)  
• The 21st Century Cures Act — A View from the NIH | NEJM

Thank you for doing this.

Jarrod

I applaud this letter and position statement. I have two points for consideration.

1. Regulatory pathways and federal policy; section 5 (RWE & clinical trials). The FDA Guidance (Aug 2023) on the use of RWD/RWE can better inform the requirements and processes needed prior to an application for label extensions and how sponsors should prepare databases for regulatory review.

2. Reforms & Reimbursement, section 4, NTAP.  Having conducted advisory boards on NTAP, one issue hindering utilization of NTAP is that Pharmacy departments, which hold the burden of antibiotic utilization costs, are kept in the dark of hospital NTAP reimbursements. Improved communication of these reimbursements can be improved so that Pharmacy Departments can see the value of tracking and using NTAP in their institutions. Possibly, Pharmacy can work internally in their institutions to better appreciate their support for NTAP programs while also monitoring the impact of newer agents and antimicrobial stewardship on the healthcare of patients.